Natural Alternatives Int'l, Inc. v. Creative Compounds, LLC

United States Court of Appeals
for the Federal Circuit
______________________
NATURAL ALTERNATIVES INTERNATIONAL,
INC.,
Plaintiff-Appellant
v.
CREATIVE COMPOUNDS, LLC,
Defendant-Appellee
DOES 1-100, CORE SUPPLEMENT
TECHNOLOGIES, INC., HONEY BADGER, LLC,
MYOPHARMA, INC.,
Defendants
______________________
2018-1295
______________________
Appeal from the United States District Court for the
Southern District of California in No. 3:16-cv-02146-H-
AGS, Judge Marilyn L. Huff.
______________________
Decided: March 15, 2019
______________________
KEVIN M. BELL, Porzio, Bromberg & Newman, PC,
Washington, DC, argued for plaintiff-appellant. Also rep-
resented by SCOTT A. M. CHAMBERS, BILLY DELL CHISM,
CAROLINE COOK MAXWELL, RICHARD J. OPARIL; MATTHEW
ZAPADKA, Bass, Berry & Sims, PLC, Washington, DC.
2 NATURAL ALTERNATIVES INTL. v. CREATIVE COMPOUNDS,
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KEVIN JOHN O’SHEA, O’Shea Law LLC, Jackson, MO,
argued for defendant-appellee.
MELISSA A. BRAND, Biotechnology Innovation Organi-
zation, Washington, DC, for amicus curiae Biotechnology
Innovation Organization. Also represented by HANSJORG
SAUER; BRIAN PAUL BARRETT, Eli Lilly and Company, Indi-
anapolis, IN.
KEVIN EDWARD NOONAN, McDonnell, Boehnen, Hulbert
& Berghoff, LLP, Chicago, IL, for amici curiae Christopher
Michael Holman, David Lund, Adam Mossoff, Kristen J.
Osenga, David O. Taylor. Also represented by AARON
VINCENT GIN.
______________________
Before MOORE, REYNA, and WALLACH, Circuit Judges.
Opinion for the court filed by Circuit Judge MOORE.
Opinion concurring-in-part and dissenting-in-part filed by
Circuit Judge REYNA.
MOORE, Circuit Judge.
Natural Alternatives International, Inc., appeals a de-
cision of the U.S. District Court for the Southern District
of California granting Creative Compounds, LLC’s motion
for judgment on the pleadings that the asserted claims of
U.S. Patent Nos. 5,965,596, 7,825,084, 7,504,376,
8,993,610, 8,470,865, and RE45,947 are not patent eligible.
Because Creative Compounds has failed to demonstrate
under Natural Alternatives’ proposed claim constructions
that the claims are not patent eligible, we reverse and re-
mand.
BACKGROUND
Natural Alternatives owns a number of patents that re-
late to dietary supplements containing beta-alanine and
have substantially similar specifications. Beta-alanine is
NATURAL ALTERNATIVES INTL. v. CREATIVE COMPOUNDS, 3
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an amino acid. Together with histidine, another amino
acid, it can form dipeptides that are found in muscles. E.g.,
’596 patent 1:59–64. The dipeptides are involved in the
regulation of intra-cellular pH during muscle contraction
and development of fatigue, and variations in dipeptide
concentrations affect the anaerobic work capacity of indi-
vidual athletes. Id. at 4:58–62, 5:1–3. One of these dipep-
tides is carnosine, which contributes to hydronium ion
buffering. Id. at 2:11–13. During certain sustained exer-
cise, hydronium ions and lactate can accumulate and se-
verely reduce intracellular pH. Id. at 1:50–54. The
reduced pH interferes with the creatine-phosphorylcrea-
tine system, a part of the process by which energy is gener-
ated in cells, particularly muscle cells. Id. at 1:31–43,
1:54–55. The claimed patents generally relate to the use of
beta-alanine in a dietary supplement to “increas[e] the an-
aerobic working capacity of muscle and other tissue.” Id.
at 2:16–18.
Natural Alternatives has asserted its patents in multi-
ple suits in the Southern District of California. Creative
Compounds moved for judgment on the pleadings, which
the district court granted. Applying the two-part test from
Alice Corp. Party Ltd. v. CLS Bank International, 573 U.S.
208, 217 (2014), it held all of the asserted claims were di-
rected to patent ineligible subject matter under 35 U.S.C.
§ 101 and lacked an inventive concept sufficient to render
them patent eligible. The district court granted judgment
in favor of Creative Compounds, and Natural Alternatives
timely appealed. We have jurisdiction under 28 U.S.C.
§ 1295(a)(1).
LEGAL STANDARDS
Section 101 of the Patent Act provides that “[w]hoever
invents or discovers any new and useful process, machine,
manufacture, or composition of matter, or any new and
useful improvement thereof, may obtain a patent therefor,
subject to the conditions and requirements of this title.”
4 NATURAL ALTERNATIVES INTL. v. CREATIVE COMPOUNDS,
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35 U.S.C. § 101. The term “process” “includes a new use of
a known process, machine, manufacture, composition of
matter, or material.” 35 U.S.C. § 100(b). The Supreme
Court has explained that under § 101, patent protection
does not extend to the patent ineligible concepts of laws of
nature, natural phenomena, and abstract ideas, which are
“building blocks of human ingenuity.” Alice, 573 U.S. at
216–17. We must therefore distinguish between claims to
patent ineligible subject matter and those that “integrate
the building blocks into something more.” Id. at 217.
In doing so, we first determine whether the claims at
issue are “directed to” a patent ineligible concept. Id. As
the Supreme Court has cautioned, we must be careful in
this analysis as “too broad an interpretation of this exclu-
sionary principle could eviscerate patent law. For all in-
ventions at some level embody, use, reflect, rest upon, or
apply laws of nature, natural phenomena, or abstract
ideas.” Mayo Collaborative Servs. v. Prometheus Labs.,
Inc., 566 U.S. 66, 71 (2012). If we determine that the
claims are directed to a patent ineligible concept, “we con-
sider the elements of each claim both individually and ‘as
an ordered combination’ to determine whether additional
elements ‘transform the nature of the claim’ into a patent-
eligible application,” i.e., whether there is an “inventive
concept.” Alice, 573 U.S. at 217 (quoting Mayo, 566 U.S. at
78–79).
Eligibility under § 101 is a question of law based on un-
derlying facts that, ultimately, we review de novo. SAP
Am. v. InvestPic, LLC, 898 F.3d 1161, 1166 (Fed. Cir.
2018). It may be resolved on a motion to dismiss where
“there are no factual allegations that, taken as true, pre-
vent resolving the eligibility question as a matter of law.”
Aatrix Software, Inc. v. Green Shades Software, Inc., 882
F.3d 1121, 1125 (Fed. Cir. 2018).
NATURAL ALTERNATIVES INTL. v. CREATIVE COMPOUNDS, 5
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DISCUSSION
The district court held that the claims at issue are not
patent eligible and dismissed. We review a district court’s
Rule 12(c) dismissal for judgment on the pleadings under
the law of the regional circuit. Amdocs (Isr.) Ltd. v. Openet
Telecom, Inc., 841 F.3d 1288, 1293 (Fed. Cir. 2016). The
Ninth Circuit reviews a court’s grant of judgment on the
pleadings de novo. Newton v. Parker Drilling Mgmt.
Servs., Ltd., 881 F.3d 1078, 1083 (9th Cir. 2018). This anal-
ysis is “functionally identical” to the standard for deciding
a motion to dismiss. Cafasso v. Gen. Dynamics C4 Sys.,
Inc., 637 F.3d 1047, 1055 n.4 (9th Cir. 2011) (quoting
Dworkin v. Hustler Magazine Inc., 867 F.2d 1188, 1192 (9th
Cir. 1989)). In doing so, the court “inquire[s] whether the
complaint’s factual allegations, together with all reasona-
ble inferences, state a plausible claim for relief.” Id. at
1055. In the Ninth Circuit, a court deciding a motion under
Rule 12 may consider “material which is properly submit-
ted as part of the complaint,” including documents that are
not physically attached to the complaint, if their authentic-
ity is not contested and the complaint necessarily relies on
them, and it may take judicial notice of matters of public
record. See Lee v. City of L.A., 250 F.3d 668, 688–89 (9th
Cir. 2001).
The district court stated that in performing its eligibil-
ity analysis, it accepted Natural Alternatives’ proposed
claim constructions. J.A. 7 n.3. This was proper given the
stage of the litigation. Applying the proposed claim con-
structions, we hold that the complaint’s factual allegations,
together with all reasonable inferences, plausibly establish
the eligibility of the representative claims. 1
1 Though the dissent suggests disagreement with
those constructions, we note that neither party argued for
6 NATURAL ALTERNATIVES INTL. v. CREATIVE COMPOUNDS,
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I.
Several of the asserted patents claim methods of treat-
ment using beta-alanine (“the Method Claims”). Claim 1
of the ’596 patent and claim 1 of the ’865 patent have been
treated as representative of the claims in those patents.
Claim 1 of the ’596 patent recites:
a different construction on appeal. The dissent’s primary
criticism is that the “effective” limitation “is not disclosed
in the plain language of the claims and is only present by
virtue of the proposed claim construction.” Dissent at 5.
Respectfully, this is not factually accurate as nearly all of
the claims of four of the patents at issue contain express
limitations requiring effectiveness. See ’865 patent 22:56–
23:29 (all claims require the amount administered be “ef-
fective to increase beta-alanylhistidine dipeptide synthesis
in the tissue”); ’596 patent 14:66–15:6 (all claims require
the amount administered be “effective to increase beta-
alanylhistidine dipeptide synthesis in the tissue”); ’084 pa-
tent 22:57–64, 23:1–24:3 (claims 13–14 and 16–18 require
the claimed method “increase beta-alanylhistidine dipep-
tide synthesis in a tissue” and “the anaerobic working ca-
pacity of the tissue is increased”); ’610 patent 22:24–23:5
(all claims require the supplement “increase[] beta-alanyl
histidine levels in muscle tissue sufficient to delay the on-
set of fatigue in the human”). The dissent also suggests the
“dietary supplement” limitation may not be a limitation be-
cause it only appears in the preamble of the claims. Dis-
sent at 6. Again, that is not correct with regard to the
claims at issue, many of which expressly include the die-
tary supplement limitation in the body. See ’865 patent
22:56–23:29 (all claims); ’610 patent 22:24–23:5 (all
claims). In other claims, the “dietary supplement” lan-
guage in the preamble provides a clear antecedent basis for
language in the body of the claims. See ’084 patent 22:25–
38 (claims 1–4).
NATURAL ALTERNATIVES INTL. v. CREATIVE COMPOUNDS, 7
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1. A method of regulating hydronium ion concen-
trations in a human tissue comprising:
providing an amount of beta-alanine to blood or
blood plasma effective to increase beta-alanylhisti-
dine dipeptide synthesis in the human tissue; and
exposing the tissue to the blood or blood plasma,
whereby the concentration of beta-alanylhistidine
is increased in the human tissue.
Claim 1 of the ’865 patent recites:
1. A method of increasing anaerobic working capac-
ity in a human subject, the method comprising:
a) providing to the human subject an amount of an
amino acid to blood or blood plasma effective to in-
crease beta-alanylhistidine dipeptide synthesis in
the tissue, wherein said amino acid is at least one
of:
i) beta-alanine that is not part of a dipep-
tide, polypeptide or oligopeptide;
ii) an ester of beta-alanine that is not part
of a dipeptide, polypeptide or oligopeptide;
or
iii) an amide of beta-alanine that is not part
of a dipeptide, polypeptide or oligopeptide;
and
b) exposing the tissue to the blood or blood plasma,
whereby the concentration of beta-alanylhistidine
is increased in the tissue,
wherein the amino acid is provided through a die-
tary supplement.
Natural Alternatives’ proposed construction of the “effec-
tive” limitations is to “elevates beta-alanine above natural
8 NATURAL ALTERNATIVES INTL. v. CREATIVE COMPOUNDS,
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levels to cause an increase in the synthesis of beta-alanyl-
histidine dipeptide in the tissue.” J.A. 579–81. It defines
“dietary supplement” as “an addition to the human diet,
which is not a natural or conventional food, which effec-
tively increases athletic performance when administered to
the human over a period of time.” J.A. 581. It also defines
“increasing anaerobic working capacity” as “increasing the
amount of work performed by a muscle under lactate pro-
ducing conditions.” J.A. 580.
The district court held both claims are directed to nat-
ural laws. It held claim 1 of the ’865 patent is directed to
the natural law that “ingesting certain levels of beta-ala-
nine, a natural substance, will increase the carnosine con-
centration in human tissue and, thereby, increase the
anaerobic working capacity in a human.” J.A. 22. It held
claim 1 of the ’596 patent is directed to the natural law that
“ingesting certain levels of beta-alanine, a natural sub-
stance, will increase the carnosine concentration in human
tissue and, thereby, aid in regulating hydronium ion con-
centration in the tissue.” J.A. 21. We do not agree.
Administering certain quantities of beta-alanine to a
human subject alters that subject’s natural state. Specifi-
cally, homeostasis is overcome, and the subject’s body will
produce greater levels of creatine. See ’596 patent 5:27–35.
This, in turn, results in specific physiological benefits for
athletes engaged in certain intensive exercise. See ’596 pa-
tent 5:21–23. The claims not only embody this discovery,
they require that an infringer actually administer the dos-
age form claimed in the manner claimed, altering the ath-
lete’s physiology to provide the described benefits. These
are treatment claims and as such they are patent eligible.
As we explained in Vanda Pharmaceuticals Inc. v.
West-Ward Pharmaceuticals International Ltd., 887 F.3d
1117, 1134–36 (Fed. Cir. 2018), claims that are directed to
particular methods of treatment are patent eligible. The
claims in Vanda involved a method of treating patients
NATURAL ALTERNATIVES INTL. v. CREATIVE COMPOUNDS, 9
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with schizophrenia that first required performing a genetic
test to determine if a patient was a CYPD2D6 performer.
Id. at 1121. Based on the results of that test, a particular
dose of iloperidone was selected and internally adminis-
tered. Id. As a result, the risk of QTc prolongation, a dan-
gerous side effect, was decreased. Id. at 1121 & n.2. We
held that the claims were not directed to a natural relation-
ship between iloperidone, CYP2D6 metabolism, and QTc
prolongation. Id. at 1134. While we acknowledged that the
inventors had recognized the underlying relationships, we
explained that those were not what was claimed. Id. at
1135. Instead, the claims were directed to a patent-eligible
method of using iloperidone to treat schizophrenia, “a spe-
cific method of treatment for specific patients using a spe-
cific compound at specific doses to achieve a specific
outcome.” Id. at 1136.
Unlike the claims held ineligible in Mayo, which re-
quired only the observation of a natural law, the Vanda
claims required a doctor to affirmatively administer a drug
to alter a patient’s condition from their natural state. Id.
at 1135. In Mayo, the discovery underlying the claims was
that when blood levels were above a certain level harmful
effects were more likely and when they were below another
level the drug’s beneficial effects were lost. Nothing in the
claim required any application of that discovery beyond the
“steps that must be taken in order to apply the laws in
question.” Mayo, 566 U.S. at 82. The claims at issue in
Mayo involved administering a prior art drug to a subject
and determining the level of drug metabolite in that sub-
ject. Id. at 74–75. The claims further provided that partic-
ular levels of measured metabolite indicated a need to
increase or decrease the amount of drug subsequently ad-
ministered to the subject. Id. at 75. The claims did not,
however, require any actual action be taken based on the
measured level of metabolite. Id. at 75–76. The claim,
therefore, “was not a treatment claim,” because “it was ‘not
limited to instances in which the doctor actually decreases
10 NATURAL ALTERNATIVES INTL. v. CREATIVE COMPOUNDS,
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(or increases) the dosage level.’” Vanda, 887 F.3d at 1136
(quoting Mayo, 566 U.S. at 76). This was expressly recog-
nized in Mayo, which distinguished the Mayo claim from “a
typical patent on a new drug or a new way of using an ex-
isting drug,” because the Mayo claim did not “confine [its]
reach to particular applications” of the natural laws relied
upon. 566 U.S. at 87 (emphasis added). Such claims rely
on the relationship between the administration of the drug
and the physiological effects in the patient. The fact that
the human body responds to the treatment through bio-
chemical processes does not convert the claim into an inel-
igible one. As we explained in Rapid Litigation
Management Ltd. v. CellzDirect, Inc., 827 F.3d 1042, 1049
(Fed. Cir. 2016), the “natural ability of the subject matter
to undergo the process does not make the claim ‘directed to’
that natural ability.”
The Method Claims are directed to patent eligible new
ways of using an existing product, beta-alanine, they are
treatment claims. This falls clearly within the scope of
§ 101, which allows for patents on “any new and useful pro-
cess,” including “a new use of a known . . . composition of
matter, or material.” 35 U.S.C. §§ 100(b), 101. As the Su-
preme Court explained in Mayo, such patents on a new use
of an existing drug are “typical.” 566 U.S. at 87.
While the Method Claims have similarities to the
claims found ineligible in Mayo, as they utilize an underly-
ing natural law, this is not sufficient to establish that they
are directed to that law. In Mayo, the Court held the claims
did not do significantly more than simply describe the nat-
ural “relationships between concentrations of certain me-
tabolites in the blood and the likelihood that a dosage of a
thiopurine drug will prove ineffective or cause harm.” Id.
at 77. The Method Claims similarly rely on the relation-
ships between the administration of beta-alanine and beta-
alanylhistidine dipeptide synthesis, but under Natural Al-
ternatives’ constructions, the Method Claims require spe-
cific steps be taken in order to bring about a change in a
NATURAL ALTERNATIVES INTL. v. CREATIVE COMPOUNDS, 11
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subject, altering the subject’s natural state. Unlike the
claims in Mayo, the Method Claims at issue are treatment
claims.
Like the claims in Vanda, the Method Claims contain
specific elements that clearly establish they are doing more
than simply reciting a natural law. Like the Vanda claims,
which specify a patient population to be treated, the
Method Claims specify particular results to be obtained by
practicing the method. Claim 1 of the ’596 patent is di-
rected to a “method of regulating hydronium ion concentra-
tions in a human tissue,” and claim 1 of the ’865 patent is
directed to a “method of increasing anaerobic working ca-
pacity in a human subject.” Similarly, both the Vanda
claims and the Method Claims specify a compound to be
administered to achieve the claimed result. Claim 1 of the
’596 patent achieves the result through the administration
of the specific compound beta-alanine, and claim 1 of the
’865 patent requires use of one of the three specified forms
of beta-alanine. The claims in Vanda further specified the
dosages of the compound to be administered. The Method
Claims likewise contain a dosage limitation by virtue of the
“effective” limitation. As we looked to the specification in
Vanda to determine the significance of the dosing ranges,
887 F.3d at 1135, here, the specification provides a method
for calculating dosage based on a subject’s weight, ’596 pa-
tent 5:48–50. This goes far beyond merely stating a law of
nature, and instead sets forth a particular method of treat-
ment.
Similarly, the fact that the active ingredient in the sup-
plement is a molecule that occurs in nature and is con-
sumed as part of the human diet also does not alter our
analysis. 2 Creative Compounds argues that, if it were dis-
covered that beta-alanine or another natural compound
2 The U.S. Patent and Trademark Office has adopted
12 NATURAL ALTERNATIVES INTL. v. CREATIVE COMPOUNDS,
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can be used to treat or cure Alzheimer’s or some other dis-
ease, the method for doing so would not be patent eligible.
Appellee Br. 28–29; Oral Arg. at 15:10–35. That is not the
case before us. That flies in the face of the Patent Act,
which expressly permits patenting a new use of an existing
product. 35 U.S.C. §§ 100(b), 101. The Supreme Court has
also rejected the idea that claims to methods making use of
natural products are equivalent to claims to the natural
products themselves. See Ass’n for Molecular Pathology v.
Myriad Genetics, Inc., 569 U.S. 576, 595 (2013) (distin-
guishing between method claims for manipulating genes
and claims to the genes); Funk Brothers Seed Co. v. Kalo
Inoculant Co., 333 U.S. 127, 130 (1948) (“We do not have
presented the question whether the methods of selecting
and testing the non-inhibitive strains are patentable. We
have here only product claims.”). Moreover, while beta-al-
anine may exist in nature, Natural Alternatives has ar-
gued that the quantities being administered do not, and
that the claimed consumption greatly exceeds natural lev-
els. See J.A. 580–81 (providing a construction of the “effec-
tive” limitation in each of the Method Claims to mean
guidance on how examiners should determine whether a
claim is eligible under § 101 and provided examples of eli-
gible and ineligible claims. Under these guidelines, a claim
to a practical application of a natural product to treat a
particular disease is patent eligible. The parties dispute
the persuasiveness of this document and the weight we
should afford it under Skidmore v. Swift & Co., 323 U.S.
134 (1944). The issue before us is a matter of law and the
result is clear, thus this is not a case in which Skidmore
deference would affect the outcome.
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“elevates beta-alanine above natural levels to cause an in-
crease in the synthesis of beta-alanylhistidine in the tis-
sue” (emphasis added)). 3
The Method Claims at issue are treatment claims.
They cover using a natural product in unnatural quantities
to alter a patient’s natural state, to treat a patient with
specific dosages outlined in the patents. We hold, there-
fore, that the Method Claims are not directed to ineligible
subject matter.
Moreover, at step two, factual impediments exist to re-
solving the case at this stage. Claim 1 of the ’865 patent
requires “the amino acid is provided through a dietary sup-
plement,” with the dietary supplement limitation con-
strued as “an addition to the human diet, which is not a
natural or conventional food.” J.A. 581 (emphasis added).
Creative Compounds argues that the “inventors admitted
in the ’865 patent, and all of the patents-on-appeal, that
placing a natural substance into a dietary supplement for
administration to a human, in order to increase the func-
tion of tissues is a conventional, well-known activity.” Ap-
pellee Br. 37 (citing ’865 patent 1:41–44). The language it
cites, however, does not stand for that proposition. In-
stead, the patent states “[n]atural food supplements are
typically designed to compensate for reduced levels of nu-
trients in the modern human and animal diet. In particu-
lar, useful supplements increase the function of tissues
when consumed.” ’865 patent 1:41–44. At most, this lan-
guage shows that the prior art contained food supplements
containing natural products, and typically those were used
to compensate for reduced levels of nutrients. It does not
establish that the dietary supplement in the claims, which
3 Indeed, the record contains an expert declaration
stating that “one 3.2 gram daily supplement of beta-ala-
nine is the equivalent to eating at least 109 Big Macs per
day.” J.A. 914.
14 NATURAL ALTERNATIVES INTL. v. CREATIVE COMPOUNDS,
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provides a dose well in excess of the normal levels of beta-
alanine, would have been well-understood, routine, and
conventional. While a fact-finder may ultimately deter-
mine that the dietary supplement limitation was well-un-
derstood, routine, and conventional, absent a clear
statement to that effect in the specification, complaint, or
other material properly before the court, when disputed
such a determination may not be made on a motion for
judgment on the pleadings.
Under Natural Alternatives’ proposed claim construc-
tions, the Method Claims are not directed to an exception
to § 101 under the first step of the Alice test. Therefore,
judgment on the pleadings was inappropriate.
II.
The district court also considered the patent eligibility
of a number of claims to dietary supplements (“the Product
Claims”). The parties and the district court treated claim 6
of the ’376 patent and claim 1 of the ’084 patent as repre-
sentative of the claims in those patents. Claim 6 of the ’376
patent depends on claims 1 and 5. In its opinion, the dis-
trict court also held representative claim 34 of the ’947 pa-
tent ineligible. Representative claim 34 of the ’947 patent
recites:
34. A human dietary supplement for increasing hu-
man muscle tissue strength comprising a mixture
of creatine, a carbohydrate and free amino acid
beta-alanine that is not part of a dipeptide, poly-
peptide or an oligopeptide, wherein the human di-
etary supplement does not contain a free amino
acid L-histidine, wherein the free amino acid beta-
alanine is in an amount that is from 0.4 g to 16.0 g
per daily dose, wherein the amount increases the
muscle tissue strength in the human, and wherein
the human dietary supplement is formulated for
one or more doses per day for at least 14 days.
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Although Natural Alternatives argued that claim 34 is eli-
gible as it is a treatment claim with a very specific dosing
regimen contained within the claim itself, at oral argument
Natural Alternatives acknowledged that this patent was
not asserted against Creative Compounds. Oral Arg. 0:52–
1:20. Though rendered ineligible in the same district court
opinion as the other patents at issue in this appeal, the ’947
patent was not asserted against Creative Compounds. 4
Claims not asserted in this litigation against this appellee,
Creative Compounds, are not properly before this court in
this appeal. This does not prejudice the patentee’s ability
to defend the eligibility of the ’947 patent in future proceed-
ings.
Turning to the Product Claims before us, claim 6 of the
’376 patent depends on claims 1 and 5.
1. A composition, comprising:
glycine; and
a) an amino acid selected from the group
consisting of a beta-alanine, an ester of a
beta-alanine, and an amide of a beta-ala-
nine, or
b) a di-peptide selected from the group con-
sisting of a beta-alanine di-peptide and a
beta-alanylhistidine di-peptide.
5. The composition of claim 1, wherein the compo-
sition is a dietary supplement or a sports drink.
4 The ’947 patent was asserted in a related litigation
against Hi-Tech Pharmaceuticals, Inc. At the time of oral
argument, that case was stayed. That case against that
defendant is not part of the present appeal.
16 NATURAL ALTERNATIVES INTL. v. CREATIVE COMPOUNDS,
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6. The composition of claim 5, wherein the dietary
supplement or sports drink is a supplement for hu-
mans.
Claim 1 of the ’084 patent recites:
1. A human dietary supplement, comprising a beta-
alanine in a unit dosage of between about 0.4
grams to 16 grams, wherein the supplement pro-
vides a unit dosage of beta-alanine.
Natural Alternatives proposed construing “dietary supple-
ment” in the ’376 patent and “human dietary supplement”
in the ’084 patent to mean “an addition to the human diet,
which is not a natural or conventional food, which effec-
tively increases athletic performance and is manufactured
to be used over a period of time.” J.A. 572, 574.
The district court held that the Product Claims are di-
rected to ineligible subject matter. It held claim 6 of the
’376 patent is directed to the natural phenomena of beta-
alanine and glycine and claim 1 of the ’084 patent is di-
rected to the natural phenomenon of beta-alanine. We do
not agree.
Although beta-alanine is a natural product, the Prod-
uct Claims are not directed to beta-alanine. A claim to a
manufacture or composition of matter made from a natural
product is not directed to the natural product where it has
different characteristics and “the potential for significant
utility.” See Diamond v. Chakrabarty, 447 U.S. 303, 310
(1980). Just as the Method Claims are directed to specific
methods of treatment that employ a natural law, the Prod-
uct Claims are directed to specific treatment formulations
that incorporate natural products, but they have different
characteristics and can be used in a manner that beta-ala-
nine as it appears in nature cannot.
In the Product Claims, beta-alanine and glycine are in-
corporated into particular dosage forms. Claim 6 of the
’376 patent is directed to a “dietary supplement or sports
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drink” that uses a combination of glycine and one of the
specified forms of beta-alanine. Under Natural Alterna-
tives’ claim constructions, the quantity of beta-alanine
must be sufficient to “effectively increase[] athletic perfor-
mance,” and the specification provides a method for deter-
mining such an amount. Similarly, the “dietary
supplement” in claim 1 of the ’084 patent uses the product
beta-alanine at a dosage of “between about 0.4 grams to 16
grams” to “effectively increase[] athletic performance.” In
each case, the natural products have been isolated and
then incorporated into a dosage form with particular char-
acteristics. At this stage in the litigation, it has been suf-
ficiently alleged that these characteristics provide
significant utility, as the claimed dosage forms can be used
to increase athletic performance in a way that naturally
occurring beta-alanine cannot. Accordingly, neither claim
is directed to ineligible subject matter.
Moreover, even though claim 6 contains a combination
of glycine and beta-alanine, both of which are natural prod-
ucts, that is not necessarily sufficient to establish that the
claimed combination is “directed to” ineligible subject mat-
ter. The Court’s decision in Funk Brothers does not stand
for the proposition that any combination of ineligible sub-
ject matter is itself ineligible. In Funk Brothers, the Court
held that claims to a mixture of two naturally occurring
bacteria were not patent eligible where each bacteria spe-
cies in the claimed combination “ha[d] the same effect it
always had,” and the “combination of species produce[d] . . .
no enlargement of the range of their utility.” 333 U.S. at
131. The combination of the bacteria into the same pack-
age did “not improve in any way their natural function.”
Id. Here, as Creative Compounds’ counsel acknowledged
at oral argument, the record indicates that the claimed
combination of glycine and beta-alanine could have syner-
gistic effects allowing for outcomes that the individual com-
ponents could not have. Oral Arg. 24:45–51, 28:00–29:30.
18 NATURAL ALTERNATIVES INTL. v. CREATIVE COMPOUNDS,
LLC
Given that this is the pleading stage, we would have to ac-
cept this statement as true even if it were just an allegation
in the pleadings. Instead, what we have goes far beyond
that, including a statement in an article attached to an ex-
pert report explaining that “one of insulin’s effects is to in-
crease amino acid (such as beta-alanine) into our cells,”
J.A. 1063, a statement in the specification that “[i]t may be
that glycine enhances insulin sensitivity,” ’376 patent at
6:3–5, and an expert declaration explaining that direct sup-
plementation of a different amino acid had no effect unless
“co-supplemented with glucose or other compounds in-
creasing the concentration of insulin in circulation,”
J.A. 1132. All of these suggest that when combined the
beta-alanine and glycine have effects that are greater than
the sum of the parts. At a minimum, there are sufficient
factual allegations to render judgment on the pleadings in-
appropriate. Accordingly, given the factual allegations,
these claims would still survive a motion for judgment on
the pleadings at the first step of the Alice test.
Finally, even if the Product Claims were directed to in-
eligible subject matter, judgment on the pleadings would
still be inappropriate under step two. Like claim 1 of the
’865 patent, the Product Claims contain a dietary supple-
ment limitation, with the same proposed construction. See
J.A. 572, 574. As we explained with regard to the Method
Claims, the specification does not contain language sup-
porting the idea that this limitation was well-understood,
routine, and conventional. The language in the specifica-
tion does not support this proposition, and patentee’s claim
construction contradicts Creative Compounds’ position, so
such a determination may not be made on a motion for
judgment on the pleadings.
III.
The parties and the district court have treated claim 1
of the ’610 patent as representative of the claims in that
patent (“the Manufacturing Claims”). It recites:
NATURAL ALTERNATIVES INTL. v. CREATIVE COMPOUNDS, 19
LLC
1. Use of beta-alanine in manufacturing a human
dietary supplement for oral consumption;
supplying the beta-alanine, which is not part of a
dipeptide, polypeptide or oligopeptide, as a single
ingredient in a manufacturing step of the human
dietary supplement or
mixing the beta-alanine, which is not part of a di-
peptide, polypeptide or oligopeptide, in combina-
tion with at least one other ingredient for the
manufacture of the human dietary supplement,
whereby the manufactured human dietary supple-
ment is for oral consumption of the human dietary
supplement in doses over a period of time increases
beta-alanyl histidine levels in muscle tissue suffi-
cient to delay the onset of fatigue in the human.
Natural Alternatives proposed construing “[u]se of beta-al-
anine in manufacturing a human dietary supplement” to
mean “making an addition to the human diet using beta-
alanine, which is not a natural or conventional food, to be
administered over a period of time and that effectively in-
creases athletic performance.” J.A. 574. It proposed con-
struing “supplying the beta-alanine, which is not part of a
dipeptide, polypeptide or oligopeptide, as a single ingredi-
ent in a manufacturing step of the human dietary supple-
ment” to mean “providing the free amino acid beta-alanine,
an ester of beta-alanine or an amide of beta-alanine in a
step of making an addition to the human diet using beta-
alanine as the only active ingredient, which is not a natural
or conventional food, which effectively increases athletic
performance when administered to a human over a period
of time.” J.A. 575. It proposed construing “mixing the
beta-alanine, which is not part of a dipeptide, polypeptide
or oligopeptide, in combination with at least one other in-
gredient for the manufacture of the human dietary supple-
ment” to mean “making an addition to the human diet,
20 NATURAL ALTERNATIVES INTL. v. CREATIVE COMPOUNDS,
LLC
which is not a natural or conventional food, and which ef-
fectively increases athletic performance when adminis-
tered to a human over a period of time, using the free amino
acid beta-alanine, an ester of beta-alanine or an amide of
beta-alanine and at least one other ingredient.” J.A. 575.
The district court held claim 1 of the ’610 patent is di-
rected to “the natural phenomenon beta alanine and the
natural law that ingesting certain levels of beta-alanine
will increase the carnosine concentration in human tissue.”
J.A. 24. We do not agree. The Manufacturing Claims are
not directed to the natural law or product of nature, but
instead are an application of the law and new use of that
product. Claim 1 of the ’610 patent is even further removed
from the natural law and product of nature at issue in the
Method Claims and Product Claims, respectively. It is di-
rected to the manufacture of a human dietary supplement
with certain characteristics. The supplement is not a prod-
uct of nature and the use of the supplement to achieve a
given result is not directed to a law of nature. We do not
see, therefore, how a claim to the manufacture of a non-
natural supplement would be directed to the law of nature
or natural product.
CONCLUSION
The claims at issue are not directed to ineligible subject
matter under step one of the Alice test. We live in the nat-
ural world, and all inventions are constrained by the laws
of nature. As the Supreme Court has warned, we must be
careful not to overly abstract claims when performing the
Alice analysis. For the foregoing reasons, we reverse the
district court’s decision that the claims are directed to inel-
igible subject matter, and we remand for further proceed-
ings consistent with this opinion.
REVERSED AND REMANDED
United States Court of Appeals
for the Federal Circuit
______________________
NATURAL ALTERNATIVES INTERNATIONAL,
INC.,
Plaintiff-Appellant
v.
CREATIVE COMPOUNDS, LLC,
Defendant-Appellee
DOES 1-100, CORE SUPPLEMENT
TECHNOLOGIES, INC., HONEY BADGER, LLC,
MYOPHARMA, INC.,
Defendants
______________________
2018-1295
______________________
Appeal from the United States District Court for the
Southern District of California in No. 3:16-cv-02146-H-
AGS, Judge Marilyn L. Huff.
______________________
REYNA, Circuit Judge, concurring-in-part, dissenting-in-
part.
The majority reverses the district court’s grant of Cre-
ative Compounds’ motion for judgment on the pleadings
under Federal Rule of Civil Procedure 12(c), which alleged
that the asserted patents claim patent ineligible subject
matter under 35 U.S.C. § 101, and remands the case for
further proceedings. I dissent from my colleagues’ broad
2 NATURAL ALTERNATIVES INTL. v. CREATIVE COMPOUNDS,
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stroke of eligibility, primarily because I conclude that the
majority’s § 101 analysis relies on an erroneous claim con-
struction. I concur, however, in the result reached by the
majority to remand for further proceedings, which I expect
permits the district court to revisit the § 101 question un-
der a proper claim construction. 1
DISCUSSION
In construing claims, we give words the ordinary and
customary meaning that the term would have to a person
of ordinary skill in the art. Phillips v. AWH Corp., 415 F.3d
1303, 1312 (Fed. Cir. 2005) (en banc). In some cases, the
ordinary meaning “may be readily apparent even to lay
judges, and claim construction in such cases involves little
more than the application of the widely accepted meaning
of commonly understood words.” Id. at 1314. This is such
a case. For example, applying ordinary and customary
meaning to the terms of claim 1 of the ’084 patent, I would
conclude as a matter of law that the claim is ineligible un-
der § 101.
Claim 1 of the ’084 patent recites:
1. A human dietary supplement, comprising a beta-
alanine in a unit dosage of between about 0.4
grams to 16 grams, wherein the supplement pro-
vides a unit dosage of beta-alanine.
1 See O2 Micro Int’l Ltd. v. Beyond Innovation Tech.
Co., 521 F.3d 1351, 1362–63 (Fed. Cir. 2008) (“When the
parties present a fundamental dispute regarding the scope
of a claim term, it is the court’s duty to resolve it. Because
we determine that the district court is in the best position
to determine the proper construction of this claim term in
the first instance, we remand for further proceedings con-
sistent with this opinion.”).
NATURAL ALTERNATIVES INTL. v. CREATIVE COMPOUNDS, 3
LLC
’084 patent col. 22 ll. 26–29. Claim 1 is directed to what is
undisputedly a naturally occurring substance, beta-ala-
nine. See id.; Appellant Br. 4. This natural substance is
applied by wholly conventional and natural means, adding
it to a human’s diet. Claim 1 discloses nothing else. In
particular, the claim discloses no basis to argue that the
claimed beta-alanine is transformed into something other
than beta-alanine. Claim 1, therefore, recites patent ineli-
gible subject matter.
The majority concludes that claim 1 is patent eligible.
My main concern with its analysis is that it relies on a
claim construction that improperly imports limitations into
the claims and is contradicted by the written description.
This may be an unavoidable result given the lack of claim
construction in this case.
Natural Alternatives argued that the district court
should construe the claims before resolving the motion for
judgment on the pleadings. Creative Compounds asserted
that, for purposes of the motion, the claims were ineligible
both under its proposed construction and Natural Alterna-
tives’ proposed construction.
The district court did not construe the claims, nor did
it conclusively adopt either party’s proposed claim con-
struction. Instead, the court determined that, for purposes
of the motion, it would review the claims under Natural
Alternatives’ proposed claim construction, an approach
that, in the district court’s view, would obviate the need to
defer deciding the motion until after it conducted claim
construction. 2
2 The majority points out that neither party argued
for a different construction on appeal. But I believe that is
only a reflection of the procedural posture of this case. This
appeal concerns the district court’s grant of a Rule 12(c)
motion, where the court adopted Natural Alternatives’
4 NATURAL ALTERNATIVES INTL. v. CREATIVE COMPOUNDS,
LLC
On appeal, Natural Alternatives argues that the dis-
trict court ignored its proposed claim construction. Appel-
lant Br. 19–20. Natural Alternatives asserts that we
should adopt its proposed construction and “remand the
case back to the District Court to engage in the proper pro-
cedure directed by Markman.” Appellant Br. 2.
As to claim 1 of the ’084 patent, Natural Alternatives
proposed the following claim construction to the district
court:
(1) “human dietary supplement” be construed
as “an addition to the human diet, ingested as a
pill, capsule, powder or liquid, which is not a natu-
ral or conventional food, meat or food flavoring or
extract, or pharmaceutical product which effec-
tively increases the function of a tissue when ad-
ministered to the human over a period of time”
J.A. 14 n.8.
(2) “dietary supplement” be construed as “an
addition to the human diet, which is not a natural
or conventional food, which effectively increases
athletic performance and is manufactured to be
used over a period of time.” J.A. 14 n.8.
Creative Compounds proposed that “dietary supple-
ment” be construed as:
“An ingredient such as a vitamin, mineral,
herb, amino acid, concentrate, or extract intended
for ingestion, which adds further nutritional value
to the diet by increasing tissue function.” J.A. 586.
proposed construction to evaluate patent eligibility in
plaintiff’s favor. Because of that, the appeal was premised
under Natural Alternatives’ construction. On remand,
however, I do not read the majority’s decision as one that
precludes claim construction.
NATURAL ALTERNATIVES INTL. v. CREATIVE COMPOUNDS, 5
LLC
I find that Natural Alternatives’ construction of “hu-
man dietary supplement” and “dietary supplement” im-
properly imports limitations into the claims, incorporates
a definition that is contrary to the plain meaning of the
terms, and is flawed because it is contradicted by the writ-
ten description.
For example, the construction imports the limitation
that beta-alanine “effectively increases the function of a
tissue when administered to the human over a period of
time.” 3 This limitation is not disclosed in the plain lan-
guage of the claims and is only present by virtue of the pro-
posed claim construction. 4
3 Likewise, for claim 6 of the ’376 patent, the added
limitation is that it “effectively increases athletic perfor-
mance when administered to the human over a period of
time.”
4 The majority states that it is not accurate to criti-
cize the claims on the basis that the “effective” limitation
does not appear in the plain language of the claims. I dis-
agree. First, while some of the asserted claims use the
word “effective,” not all do. Claim 1 of the ’084 patent is
independent and does not include any reference to effec-
tiveness. The majority’s citations to other claims within
the ’084 patent do not detract from my basic point that “di-
etary supplement” or “human dietary supplement” do not,
alone, import an effectiveness component as the proposed
construction requires. Likewise, none of the asserted
claims of the ’376 patent include any reference to effective-
ness. Second, if “dietary supplement,” as a term, included
an effectiveness component, this would undermine the ne-
cessity for claim 1 of the ’865 patent to use the term “effec-
tive.” In other words, the fact that some claims use
“effective” to reflect that limitation undercuts a construc-
tion that such limitation exists within the definition of “di-
etary supplement” or “human dietary supplement.” Lastly,
6 NATURAL ALTERNATIVES INTL. v. CREATIVE COMPOUNDS,
LLC
Natural Alternatives’ proposed construction are also
contradicted by the written description. For example, the
proposed construction of “human dietary supplement” lim-
its the claim in the ’084 patent to dietary supplements that
are: (1) ingested in pill, capsule, powder, or liquid form; (2)
not meat or food flavoring or extract, or a pharmaceutical
product; (3) effective to increase the function of tissues over
time; and (4) not natural or conventional food. Appellant
Br. 20; J.A. 14 n.8. Yet the specification notes that “[t]he
compositions of the invention can be used for the prepara-
tion of a dietary supplement (including, e.g., drinks, gels,
foods) or pharmaceutical compositions for humans or ani-
mals.” ’084 patent col. 5 ll. 13–16. On the one hand, the
construction excludes pharmaceutical products and foods,
while on the other hand, the specification expressly in-
cludes foods within the definition of “dietary supplement”
and expands the scope of the invention to include “pharma-
ceutical compositions” for humans or animals.
Interestingly, the District of Delaware, in evaluating a
related patent, declined to construe “dietary supplement,”
holding that the term was not a limitation. Natural Alter-
natives Int’l Inc. v. Vital Pharm. Inc., No. 1:09-CV-00626,
Dkt. No. 125 at 2 (D. Del. May 31, 2011) (“Delaware Or-
der”). The court noted that “dietary supplement” appeared
only in the preamble of the claims and that the specifica-
tions did not demonstrate that the term was a necessary
aspect of the invention. 5 Id.
even for the claims that use “effective,” that limitation still
depends on Natural Alternatives’ proposed claim construc-
tion of “effective” as “elevat[ing] beta-alanine above natural
levels to cause an increase in the synthesis of beta-alanyl-
histidine dipeptide in the tissue.” J.A. 579–81 (emphasis
added).
5 The majority contends that, through this citation, I
am incorrectly suggesting that “dietary supplement” may
NATURAL ALTERNATIVES INTL. v. CREATIVE COMPOUNDS, 7
LLC
Natural Alternatives’ construction also defines “human
dietary supplement” to “effectively increase[]” the function
of a tissue over time. 6 J.A. 14 n.8. This definition is
not be a limitation. To be clear, that is what the District of
Delaware held, and I raise that holding to underscore the
complexities about the proposed construction, particularly
because one of the patents at issue in the Delaware case
(U.S. Patent. No. 6,426,361) had similar claims as those
here. For example, claims 1 and 5 of the ’361 patent recite:
1. A composition comprising a mixture of a creatine
and a composition comprising an amino acid or an
active derivative thereof selected from the group
consisting of a beta-alanine, an ester of a beta-ala-
nine and an amide of a beta-alanine.
....
5. A dietary supplement comprising a mixture of a
creatine and a composition comprising an amino
acid or an active derivative thereof selected from
the group consisting of a beta-alanine, an ester of a
beta-alanine and an amide of a beta-alanine.
’361 patent col. 15 ll. 17–21, 30–34. In concluding that “di-
etary supplement” was not a limitation, the court pointed
out that “the specification simply notes that the claimed
‘composition can be a dietary supplement.’” Delaware Or-
der at 2 (citing ’361 patent col. 3 l. 41 (emphasis in origi-
nal)). The claims implicated in this case are similar to
those in the Delaware Order, and the written descriptions
likewise include this permissive—yet non-restrictive—lan-
guage. E.g., ’569 patent col. 3 l. 32; ’376 patent col. 6 l. 48;
’084 patent col. 6 l. 52; ’865 patent col. 6 l. 53; ’610 patent
col. 6 l. 54.
6 For the ’376 patent the construction defines “die-
tary supplement” to effectively increase athletic perfor-
mance. J.A. 14 n.8.
8 NATURAL ALTERNATIVES INTL. v. CREATIVE COMPOUNDS,
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contrary to the plain meaning of the term: “a product taken
orally that contains one or more ingredients which are in-
tended to supplement one’s diet and are not considered
food.” 7 Nor is this a case where the patentee has acted as
its own lexicographer. Thorner v. Sony Computer Entm’t
Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012). To do so,
“a patentee must ‘clearly set forth a definition of the dis-
puted claim term’ other than its plain and ordinary mean-
ing.” Id. (quoting CCS Fitness, Inc. v. Brunswick Corp., 288
F.3d 1359, 1366 (Fed. Cir. 2002)). Nowhere does the pa-
tentee set forth such a definition. 8
This court is hesitant to construe claims for the first
time on appeal. Meyer Intellectual Props. Ltd. v. Bodum,
Inc., 690 F.3d 1354, 1368 (Fed. Cir. 2012). This tendency
reflects a concern to avoid conflating de novo review with
7 Dietary supplement, Merriam-Webster Una-
bridged, http://unabridged.merriam-webster.com/una-
bridged/dietarysupplement; see also Phillips, 415 F.3d at
1314 (general purpose dictionaries are helpful when con-
struction involves widely accepted meaning of commonly
understood words); Optical Disc Corp. v. Del Mar Avionics,
208 F.3d 1324, 1334–35 (Fed. Cir. 2000) (“Without evidence
in the patent specification of an express intent to impart an
innovative meaning to a claim term, the term takes on its
ordinary meaning. For such ordinary meaning, we turn to
the dictionary definition of the term.” (internal citations
omitted)).
8 Notably, the definitions of “dietary supplement” set
out by the Food and Drug Administration, J.A. 590, and the
Dietary Supplement Health and Education Act, 21 U.S.C.
§ 321(ff), also do not reflect a functional/effectiveness com-
ponent within the meaning of the term. That is, these def-
initions do not support a finding that the effective increase
of athletic performance or tissue function is embedded
within the meaning of “dietary supplement.”
NATURAL ALTERNATIVES INTL. v. CREATIVE COMPOUNDS, 9
LLC
an independent analysis in the first instance. See Wavetro-
nix LLC v. EIS Elec. Integrated Sys., 573 F.3d 1343, 1355
(Fed. Cir. 2009) (noting this court’s review of claim con-
struction without deference is not an independent analysis
in the first instance (citing Nazomi Commc’ns, Inc. v. Arm
Holdings, PLC, 403 F.3d 1364, 1371 (Fed. Cir. 2005))).
Construing claims on appeal, however, is proper under lim-
ited circumstances, particularly when the record is suffi-
ciently developed to enable construction. See e.g., Meyer,
690 F.3d at 1369; Wavetronix, 573 F.3d at 1355. I do not
see such a record in this case. Apparently, the majority
agrees because it too did not construe the claims, but rather
choose to rely on the construction proposed by Natural Al-
ternatives.
If anything, this appeal was pre-ordained to result in a
remand. The district court decided the Rule 12(c) motion
at the pleading stage while acknowledging that it could de-
fer its decision until after it conducted claim construction.
On appeal, Natural Alternatives argues that the district
court erred when it decided not to conduct claim construc-
tion before deciding the motion. The majority remands to
the district court for further proceedings, which I take to
mean could include a formal claim construction and a po-
tential revisit of the § 101 issue.
I would remand because I believe the district court and
the majority relied on an erroneous claim construction. So,
the question is whether anything meaningful has been
achieved in these circumstances. This case, and the gen-
eral development of the law concerning § 101 analysis at
the pleading stage, causes me to ask whether the time has
come for this court to reconsider whether a Rule 12(c) mo-
tion based on § 101 should be decided before claim con-
struction. See Bancorp Servs., L.L.C. v. Sun Life Assur. Co.
of Canada (U.S.), 687 F.3d 1266, 1273–74 (Fed. Cir. 2012)
(“[I]t will ordinarily be desirable—and often necessary—to
resolve claim construction disputes prior to a § 101 analy-
sis, for the determination of patent eligibility requires a full
10 NATURAL ALTERNATIVES INTL. v. CREATIVE COMPOUNDS,
LLC
understanding of the basic character of the claimed subject
matter.”); see e.g., Loyalty Conversion Sys. Corp. v. Am. Air-
lines, Inc., 66 F. Supp. 3d 829, 835 (E.D. Tex. 2014)
(Bryson, J.) (“[T]he Court has waited until after the claim
construction hearing in this case to rule on the [Rule 12(c)
motion] in order to ensure that there are no issues of claim
construction that would affect the Court’s legal analysis of
the patentability issue.”); Presqriber, LLC v. AO Capital
Partners LLC, No. 6:14-CV-440, 2015 WL 11578559, at *6
(E.D. Tex. Mar. 31, 2015) (denying Rule 12(b)(6) motion
without prejudice to conduct claim construction and obtain
a full understanding of the claimed invention relevant to a
§ 101 analysis).
CONCLUSION
On the basis set forth above, I concur-in-part and dis-
sent-in-part.